Product code MAC— General, Plastic Surgery

“This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.”

FDA has cleared 2 devices under product code MAC between 1989 and 2003, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20031 clearance
• 19891 clearance

• Dept. of the Army2 clearances

• K023969 — REACTIVE SKIN DECONTAMINATION LOTIONDept. of the Army·2003-03-25
• K894455 — DECONTAMINATING KIT, SKIN: M291Dept. of the Army·1989-08-15